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Johnson & Johnson recalls schizophrenia drug after discovering mold

Sep 12, 2013 Viewed: 442

Johnson & Johnson is voluntarily recalling one lot of schizophrenia drug Risperdal Consta after discovering mold during a routine testing process, a company spokeswoman said, the latest in a string of recalls over the past two years.

Risperdal Consta is manufactured by Janssen Pharmaceuticals, a unit of Johnson & Johnson. The company is recalling the drug from wholesalers, distributors, pharmacies and healthcare providers.

The medicine is a long-acting form of J&J’s Risperdal anti-psychotic medication, and is used to treat bipolar disorder and schizophrenia. It is injected, unlike basic Risperdal, which is a pill.

“We estimate that fewer than 5,000 dose packs remain in the market considering our current inventory levels and the usage of this product,” spokeswoman Robyn Reed Frenze said in an email to Reuters. A single lot of Risperdal Consta consists about 70,000 dosage packs.

Frenze said that the risk to patients is considered low, and “there have been no trends of adverse events of infection associated with this lot”.

The spokeswoman added that the medication is administered to patients by healthcare professionals only, “and it is important that patients continue their prescribed treatment”.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

(Reporting by Sakthi Prasad in Bangalore; Editing by Jeremy Laurence)

Cautions
Increased incidence of cerebrovascular disease reported
schizophrenia drug after discovering mold" width="190" align="right" /> Use with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydration
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery
Use with caution in children <15 kg
Risk of orthostatic hypotension
FDA warning regarding off-label use for dementia in elderly
Metabolic changes
Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, and body weight gain)
In some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death

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